Active not recruitingOBSERVATIONAL

Efficacy and Safety Study of DURVALUMAB Maintenance in Patients With Stage III Non-Small Cell Lung Cancer

This study is about a medicine called durvalumab, which is used to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) at a stage where surgery isn't possible. Patients in this study have already received chemotherapy and radiation therapy for their cancer. Durvalumab is then given to help keep the cancer from coming back or growing. We know this medicine has been helpful for many, but not everyone benefits in the same way. The study wants to see how well durvalumab works in real-life situations and why it works better for some people than others. By understanding this, researchers hope to improve treatments and discover new ways to help patients in the future, while also learning how to better predict side effects.

At a glance

Status

Active not recruiting

Sponsor

University Hospital, Brest

Enrolment target

200

Start

01 Jun 2021

Estimated completion

30 Dec 2024

Bronchial Cancer

What is this study about?

This research is looking into a treatment called durvalumab for a specific type of lung cancer. This cancer is known as non-small cell lung cancer and is at a stage where doctors can't remove it with surgery. Before receiving durvalumab, patients in this study would have already had a combination of chemotherapy and radiation treatment.

Durvalumab is a type of 'immunotherapy'. This means it helps your body's own immune system fight the cancer. For some time now, medicines like durvalumab have been really important in treating advanced cancers. Studies have shown that durvalumab, when given after chemotherapy and radiation, can help people with this type of lung cancer live longer without their cancer getting worse. It's already approved for use in certain patients, especially if their cancer cells show a specific marker called PD-L1.

Even though durvalumab is very helpful, it doesn't work for everyone, and about half of patients find their cancer starts to grow again within a year. Also, doctors don't yet know exactly who will get the most benefit from the treatment or who might experience certain side effects. This study aims to gather information from real patients to better understand how durvalumab works, why some people respond better than others, and how to predict and manage any side effects. This knowledge is crucial for developing even better treatments and helping more people in the future.

Key takeaways

This study focuses on a lung cancer treatment called durvalumab.
It's for people with non-surgical lung cancer who have already had chemotherapy and radiation.
Researchers want to understand how durvalumab works in real patients and why it helps some more than others.
The goal is to improve future treatments and predict who will benefit most.
Participation involves sharing information from your ongoing medical care.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. You should have a type of lung cancer called non-small cell lung cancer, which is considered 'locally advanced' – meaning it's grown quite a bit but hasn't spread too far, and surgery isn't an option. Furthermore, you must have already finished your chemotherapy and radiation treatments, and your cancer should either be stable (not getting worse) or be shrinking.

You also would need to have received durvalumab, which is the study medication, as a follow-up treatment after your chemotherapy and radiation. The radiation dose you received should have been within a specific range. Your general health should be good, meaning you can carry out most daily activities without difficulty. You also need to agree to take part in the study.

People under 18 years old cannot join. Also, if you're unable to give your consent to participate, for example, if you are under legal protection where someone else makes decisions for you, then you wouldn't be able to be part of this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have locally advanced non-small cell lung cancer that can't be removed by surgery?
Have you already completed chemotherapy and radiation for your lung cancer?
Are you currently receiving durvalumab treatment after your chemo-radiation?
Is your general health good enough for you to do most daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the researchers will be collecting information about how you respond to durvalumab treatment, which you are already receiving. This isn't a study where you are given a new or experimental drug; it's about observing how this approved treatment works in real life. This will involve regular check-ups, which might include scans, blood tests, and discussions with your medical team. These are generally part of your usual care when receiving this treatment. The study's duration would depend on how long you are receiving durvalumab and your follow-up schedule, but it would be incorporated into your ongoing cancer care.

Potential risks and benefits

The main benefit of taking part in this type of study is helping researchers learn more about how durvalumab works in real patients. This knowledge can improve treatments for future patients and help doctors decide who is most likely to benefit. Since you would already be receiving durvalumab as part of your standard care, you wouldn't be exposed to new or unknown medication risks by joining the study. However, like any medical treatment, durvalumab can have side effects, which your medical team will discuss with you. You are always free to leave the study at any time without it affecting your usual medical care.

Locations (1)

CHU de Brest
Verified postcode
Brest, France

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study focuses on a stage where surgery isn't suitable, but it hasn't spread widely across the body.

What is durvalumab?

Durvalumab is a medicine that helps your body's own immune system find and fight cancer cells. It's a type of 'immunotherapy'.

Why is this study needed if durvalumab is already approved?

Even though it's approved, doctors want to understand why it works better for some patients than others in real-life situations, and how to predict side effects.

Will I get a new treatment if I join this study?

No, this study is about observing how durvalumab, which you would already be receiving as part of your normal care, works for you. It's not testing a new drug.

What does 'consolidation therapy' mean?

It means giving a treatment, like durvalumab, after initial treatments (like radiation and chemotherapy) to try and prevent the cancer from returning or growing.